The invention generally relates to implantable cardiac stimulation devices such as pacemakers, and in particular, to techniques for overdrive pacing heart tissue to prevent or terminate dysrhythmia.
A dysrhythmia is an abnormal heart beat pattern. One example of a dysrhythmia is a bradycardia wherein the heart beats at an abnormally slow rate or where significant pauses occur between consecutive beats. Other examples of dysrhythmias include tachyarrhythmias where the heart beats at an abnormally fast rate, e.g., atrial tachycardia where the atria of the heart beat abnormally fast.
One technique for preventing or terminating dysrhythmias is to overdrive pace the heart where an implantable cardiac stimulation device, such as a pacemaker or implantable cardioverter defibrillator (ICD), applies electrical pacing pulses to the heart at a rate somewhat faster than the intrinsic heart rate of the patient. For bradycardia, the implantable cardiac stimulation device may be programmed to artificially pace the heart at a rate of 60 to 80 pulses per minute (ppm) to thereby prevent the heart from beating too slow and to eliminate any long pauses between heart beats. To prevent tachyarrhythmias from occurring, the implantable cardiac stimulation device artificially paces the heart at a rate of at least five to ten pulses per minute faster than the intrinsic tachyarrhythmia heart rate of the patient. In other words, a slight artificial tachycardia is induced and maintained in an effort to prevent an actual tachycardia from arising.
It is believed that overdrive pacing is effective in at least some patients for preventing or terminating the onset of an actual tachycardia for the following reasons. A normal, healthy heart beats only in response to electrical pulses generated from a portion of the heart referred to as the sinus node. The sinus node pulses are conducted to the various atria and ventricles of the heart via certain, normal conduction pathways. In some patients, however, additional portions of the heart also generate electrical pulses referred to as xe2x80x9cectopicxe2x80x9d pulses. Each pulse, whether a sinus node pulse or an ectopic pulse, has a refractory period subsequent thereto during which time the heart tissue is not responsive to any electrical pulses. A combination of sinus pulses and ectopic pulses can result in a dispersion of the refractory periods which, in turn, can trigger a tachycardia. By overdrive pacing the heart at a uniform rate, the likelihood of the occurrence of ectopic pulses is reduced and the refractory periods within the heart tissue are rendered uniform and periodic. Thus, the dispersion of refractory periods is reduced and tachycardias triggered thereby are substantially avoided.
Thus, it is desirable with patients prone to tachyarrhythmias to ensure that most beats of the heart are paced beats, as any unpaced beats may be ectopic beats. A high percentage of paced beats can be achieved simply by establishing a high overdrive pacing rate. However, a high overdrive pacing rate has disadvantages as well. For example, a high overdrive pacing rate may be unpleasant to the patient, particularly if the artificially-induced heart rate is relatively high in comparison with the heart rate that would otherwise normally occur. Also, a high overdrive pacing rate may be a problem in patients with coronary artery disease because increasing the heart rate decreases diastolic time and decreases perfusion, thus intensifying ischemia. Also, the need to apply overdrive pacing pulses operates to deplete the implantable cardiac stimulation device""s power supply, perhaps requiring frequent surgical replacement of the power supply. Typically, the power supply is located within the implantable cardiac stimulation device and thus this requires surgical replacement of the implantable cardiac stimulation device.
A high overdrive pacing rate may be especially problematic in patients suffering from heart failure, particularly if the heart failure is due to an impaired diastolic function. A high overdrive pacing rate may actually exacerbate heart failure in these patients. Also, a high overdrive pacing rate may be a problem in patients with coronary artery disease because increasing the heart rate decreases diastolic time and decreases perfusion, thus intensifying ischemia. Also, the need to apply overdrive pacing pulses operates to deplete the implantable cardiac stimulation device""s power supply, perhaps requiring frequent surgical replacement of the power supply. Typically, the power supply is located within the implantable cardiac stimulation device and thus this requires surgical replacement of the implantable cardiac stimulation device.
Problems associated with overdrive pacing are particularly severe for certain aggressive overdrive techniques which trigger an increase in the pacing rate based upon detection of a single intrinsic heart beat. With such techniques, a significant increase in the pacing rate is triggered by detection of a single intrinsic heart beat so as to promptly respond to the occurrence of a high rate tachycardia, such as an SVT. As a result, even in circumstances where a high rate tachycardia has not occurred, the detection of a single intrinsic heart beat can cause a significant increase in the overdrive pacing rate, which may be reduced only gradually. If a second intrinsic heart beat is detected before the overdrive pacing rate has been gradually lowered to a standard overdrive pacing rate, a still further increase in the pacing rate occurs. As can be appreciated, the foregoing can cause the overdrive pacing rate to increase significantly, perhaps to 150 ppm or more, even though a high rate tachycardia has not occurred. The aforedescribed problems are addressed by a copending, commonly-assigned patent application to Florio et al., entitled xe2x80x9cMethods and Apparatus for Overdrive Pacing Heart Tissue using an Implantable Cardiac Stimulation Device,xe2x80x9d U.S. patent application Ser. No. 09/471,788, filed Dec. 23, 1999, the contents of which are incorporated herein by reference in their entirety.
The prolongation of atrial refractoriness is also known to reduce the likelihood of atrial arrhythmias in some patients. Certain drugs, such as amiodarone or beta-blockers, like sotalol, help to maintain sinus rhythm by prolonging atrial refractoriness and thus act to reduce atrial arrhythmias in some patients. Other drugs help slow the ventricular rate once atrial fibrillation has occurred. These drugs reduce ventricular rate by AV nodal inhibition. These include verapamil, diltiazem, beta-blockers, and/or digoxin. However, drugs can cause side effects and many patients are resistant to drug therapy.
It would therefore be desirable to have some means other than the ingestion of drugs available to this patient population for prolonging atrial refractoriness. To that end, preemptive electrical stimulation of the atrium is known to prevent atrial arrhythmias in some patients. The use of such electrical stimulation is described in a copending, commonly-assigned patent application to Bornzin et al., entitled xe2x80x9cImplantable Cardiac Stimulation Device and Method for Prolonging Atrial Refractoriness,xe2x80x9d U.S. patent application Ser. No. 09/488,284, filed Jan. 20, 2000, the contents of which are incorporated herein by reference in their entirety. The Bornzin application describes an approach that uses an implantable cardiac stimulation device capable of pacing the heart of a patient while pacing the atria in an improved manner which assists in prolonging atrial refractoriness and treating atrial arrhythmias. Furthermore, this approach provides therapeutic benefit to patients with hypertension, heart failure, acute myocardial infarction, etc.
Another alternative approach to reduce atrial arrhythmias is described in U.S. Pat. No. 5,403,356 to Hill et al. (the Hill patent). The Hill patent describes placing at least two electrodes in the atrium, preferably in the triangle of Koch and/or an area of prolonged effective refractory period elsewhere in the atrium. Pacing pulses are then applied to the multiple electrodes either simultaneously or separated by a short delay.
While each approach offers benefits in avoiding incidences of arrhythmia, e.g., atrial arrhythmia, it is believed that treatment can be further improved by combining selected aspects of these approaches to achieve an improved result. Accordingly, the present invention is directed to that end.
The present invention is directed toward a method and apparatus for reducing the incidence of atrial arrhythmias by using an overdrive algorithm to determine the application of overdrive stimulation pulses to a patient""s heart, e.g., in the atria. In a first aspect of the invention, the apparatus first determines an overdrive pacing rate and then applies pairs of temporally spaced (staggered), i.e., primary and secondary, pacing pulses at the determined overdrive pacing rate. In a further aspect of the invention, the pairs of pacing pulses are applied at the overdrive pacing rate to multiple spatially spaced electrodes, i.e., electrodes distributed among multiple sites in a patient""s heart, e.g., in the atria. In accordance with a first preferred embodiment, the electrodes may be distributed within a single atrium, e.g., the right atrium, of the patient""s heart. Alternatively, a first electrode may be placed in the right atrium and a second electrode may be placed in the coronary sinus or the left atrium or multiple electrodes may be placed proximate to the left atrium.
In accordance with a further aspect of invention, a method is provided for overdrive pacing a patient""s heart using an implantable cardiac stimulation device wherein an increase in an overdrive pacing rate is performed only in response to detection of at least two intrinsic beats within a predetermined search period. Initially, an overdrive pacing rate is determined and the heart is paced at the overdrive pacing rate. Intrinsic heart beats arising during overdrive pacing are detected. If at least two intrinsic heart beats are detected within a first predetermined search period, then the overdrive pacing rate is increased by a predetermined rate increment. If at least two intrinsic heart beats are not detected within a second predetermined search period, the overdrive pacing rate is decreased by a predetermined amount. By increasing the overdrive pacing rate only in response to the detection of at least two intrinsic heart beats within the first predetermined search period, an excessively high heart rate is avoided as might otherwise occur if an overdrive pacing rate increase were based upon detection of only a single intrinsic heart beat.
In an exemplary embodiment, the first predetermined search period extends for X number of cardiac cycles following detection of a first intrinsic beat wherein X is in the range of eight to forty cycles. The second predetermined search period Z is also within the range of eight to forty cardiac cycles. If, after detection of a first intrinsic heart beat, a second heart beat is detected within X cardiac cycles, then the overdrive pacing rate is increased by Y ppm wherein Y is five, ten, fifteen, twenty or twenty-five. If Z cardiac cycles occur without a rate increase, then the rate is decreased by an amount W ppm per cardiac cycle wherein W is one, two, three, four or five.
In a second exemplary embodiment, the first predetermined search period is N consecutive cardiac cycles, wherein N is, for example, ten. Thus, if there are at least two intrinsic heart beats within a set of N consecutive cardiac cycles, the overdrive pacing rate is increased. Otherwise, the overdrive pacing rate is decreased. With the second embodiment, it is easy to program a minimum percentage of paced beats. For example, to attain at least a minimum of 90% paced beats, N is set at ten. If fewer than 90% of the beats are paced beats (i.e., at least two beats out of every ten beats are intrinsic beats), the overdrive pacing rate is increased; otherwise it is decreased. This provides a feedback loop which maintains the pacing rate at a rate sufficient to provide about 90% paced beats on the average.
In still other embodiments, the implantable cardiac stimulation device may periodically suspend overdrive pacing to permit detection of three consecutive intrinsic heart beats. The intrinsic heart rate is calculated based upon those three heart beats and overdrive pacing resumes at a rate corresponding to the intrinsic heart rate. In another embodiment, the implantable cardiac stimulation device periodically determines the intrinsic atrial rate and compares the atrial rate with the current overdrive pacing rate. If the difference between the atrial rate and the overdrive pacing rate exceeds a predetermined threshold amount, the implantable cardiac stimulation device adjusts the overdrive pacing rate to equal the atrial rate. Otherwise, the implantable cardiac stimulation device continues to pace at the current overdrive pacing rate.
In accordance with a second aspect of the invention, a method is provided for adaptively varying overdrive pacing characteristics so as to achieve a predetermined degree of pacing. Overdrive pacing pulses are applied to the heart in accordance with programmed values specifying overdrive pacing characteristics. An actual degree of pacing resulting from the overdrive pacing pulses is determined. The programmed values are then varied based upon the degree of pacing resulting from the overdrive pacing pulses.
In an exemplary embodiment of the second aspect of the invention, overdrive pacing is performed by periodically determining an intrinsic atrial rate, then pacing the heart at a rate equal to the intrinsic rate plus an additional overdrive pacing margin. The overdrive pacing margin is thereafter selectively increased or decreased so as to maintain the actual degree of pacing at about 95% paced beats. To this end, the overdrive pacing margin, which may initially be set to five beats per minute above the intrinsic heart rate, may be incrementally increased or decreased to maintain the percentage of paced beats at the target rate of about 95%.
In a second exemplary embodiment, overdrive pacing is performed in accordance with a dynamic atrial overdrive technique which operates to periodically increase a pacing cycle length (i.e., to decrease the pacing rate) to permit detection of intrinsic paced beats. The pacing cycle length is automatically extended every NMAX cardiac cycles by a predetermined amount. Initially, NMAX may be, for example, ten cycles. In accordance with the invention, the value for NMAX is periodically increased or decreased in accordance with the actual degree of pacing so as to maintain the actual degree of pacing at about 95% paced beats. Hence, possible disadvantages associated with increasing the overdrive pacing rate in response to detection of only a single intrinsic beat are substantially avoided and the average overdrive pacing rate is kept reasonably low. Other programmable values defining the dynamic atrial overdrive algorithm may also be adaptively varied in accordance with the actual degree of pacing.
Hence, with the second aspect of the invention, overdrive pacing characteristics are adaptively varied so as to reduce the average overdrive pacing rate while still maintaining, on the average, the target percentage of paced beats. The degree of risk or discomfort to the patient resulting from overdrive pacing is thereby minimized and the longevity of the power supply of the implantable cardiac stimulation device is increased while still achieving a sufficiently high percentage of paced beats to reduce the risk that a naturally occurring tachyarrhythmia will occur within the patient.
Once the overdrive pacing rate has been determined, the pacing pulses are applied as pairs of temporally spaced pacing pulses, i.e., primary and secondary pacing pulses, where the primary pacing pulse is applied according to the overdrive pacing algorithm and the secondary pacing pulse, delayed in time from the primary pacing pulse, is additionally applied to extend the refractoriness of the cardiac tissue and thus further limit the potential for a tachycardia to occur.
The invention therefore provides an implantable cardiac stimulation device, e.g., a pacemaker or ICD, including generating means for delivering pacing pulses to an atrium of a heart and control means coupled to the generating means for causing the generating means to deliver a primary pacing pulse to the atrium at the overdrive pacing rate and causing the generating means to deliver a secondary pacing pulse to the atrium a delay time after the delivery of the primary pacing pulse.
In accordance with further aspects of the present invention, the implantable cardiac stimulation device may further include a detector that detects atrial activations of the heart, wherein the generator control inhibits the generator from providing the primary pacing pulse when an atrial activation is detected during an escape interval and wherein the generator control further causes the generator to deliver the secondary pacing pulse to the atrium the delay time after an atrial activation is detected during the escape interval.
The present invention also discloses a means to automatically establish the delay timing for delivery of the secondary pacing pulse. The advantage of automated adjustment of the delivery of the secondary pacing pulse is that there is no necessity to manually adjust the interval. Additionally, if there are physiologic changes to the patient""s heart that would necessitate adjustment of the delay, it will be automatically performed by the device, thus automatically optimizing therapy.
In a significant additional aspect of the present invention, the aforedescribed overdrive algorithm used in combination with the pacing pulse pairs may be performed via multiple sites in a patient""s heart. In a first embodiment, two or more electrodes are distributed in the atria, e.g., the right atrium of the patient""s heart, and a combined signal received from the electrodes is used as input to the aforedescribed overdrive algorithm. The algorithm then triggers a single primary/secondary pulse generator which simultaneously drives multiple electrodes for simultaneously stimulating multiple sites in the patient""s heart. Alternatively, multiple primary/secondary pulse generators can be used to individually drive the multiple electrodes, thus enabling a programmed time delay between stimulation of each of the sites in the patient""s heart. Additionally, cardiac tissue depolarizations can be individually sensed from each of the electrodes and the sensed signal indicating the highest heart rate can be used as input to the overdrive algorithm. Again, pacing pulses can be applied either simultaneously or staggered with a programmed time delay to multiple sites in the patient""s heart.
Apparatus embodiments of the invention are also provided. Other aspects, features, and advantages of the invention will be apparent from the detailed description which follows in the combination with the attached drawings.